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Artemisinin to Reduce The Symptoms of Schizophrenia | Clinical Trials | Clareo Health

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Artemisinin to Reduce The Symptoms of Schizophrenia

Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia

NCT00753506•Sheppard Pratt Health System

Summary

The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the antimalarial compound artemisinin when used in addition to standard antipsychotic medications.

Detailed Description

The aims of the current study are: 1. To evaluate the efficacy and side effects of artemisinin as an add-on compound for patients with schizophrenia who have residual psychotic symptoms of at least moderate severity. 2. To evaluate the effect of artemisinin on cognitive impairments and associated functional skills. 3. To investigate whether treatment with artemisinin produces a significant effect on the levels of antibodies to Toxoplasma. 4. To examine whether changes in cognitive impairment or psychiatric symptoms are correlated with changes in antibodies to Toxoplasma before and during the treatment with artemisinin.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18-65 years old.
•Capacity for written informed consent.
•Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
•Currently an outpatient at the time of enrollment.
•Residual psychotic symptoms which are at least moderately severe as evidenced by one or more Positive and Negative Syndrome Scale (PANSS) positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
•Conformance to Patient Outcome Research Team (PORT) Treatment Recommendation #5, Maintenance Antipsychotic Medication Dose (Lehman et al., 2004).
•Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
•Participants must be proficient in English.

Exclusion Criteria

•Diagnosis of mental retardation.
•History of IV drug use.
•Any serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, brain tumor or other neurological disorder).
•HIV infection or other immunodeficiency condition.
•Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
•Participated in any investigational drug trial in the past 30 days.
•Pregnancy or planning to become pregnant during the study period.
•Any clinically significant or unstable medical disorder as determined by the investigators that would preclude study participation, including congestive heart failure, abnormal liver function or disease, renal failure, and any diagnosis of cancer undergoing active treatment.

Locations (1)

Sheppard Pratt Health System

Towson, Maryland, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

February 28, 2012

Enrollment

ACTUAL participants

Conditions

SchizophreniaSchizoaffective Disorder

Interventions

Artemisinin

DIETARY_SUPPLEMENT

Identical looking placebo capsule

DIETARY_SUPPLEMENT

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Artemisinin to Reduce The Symptoms of Schizophrenia

Inclusion Criteria

Exclusion Criteria

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